Aduhelm
E24938
Aduhelm is an Alzheimer’s disease drug developed by Biogen that targets amyloid-beta plaques in the brain.
Aliases (1)
- aducanumab ×1
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
Alzheimer's disease treatment
→
drug → monoclonal antibody → |
| administrationFrequency | once every four weeks → |
| antibodyType | IgG1 → |
| approvedBy |
Food and Drug Administration
→
surface form: "U.S. Food and Drug Administration"
|
| ATCCode | N06DX07 → |
| boxedWarning | amyloid-related imaging abnormalities → |
| clinicalTrial |
EMERGE (Study 302)
→
ENGAGE (Study 301) → |
| coDevelopedBy | Eisai → |
| commonAdverseEffect |
amyloid-related imaging abnormalities
→
confusion → diarrhea → falls → headache → |
| controversy |
accelerated approval despite mixed trial results
→
efficacy questioned by FDA advisory committee → high treatment cost → |
| developedBy | Biogen → |
| dosageForm | concentrate for solution for infusion → |
| drugClass |
anti-amyloid monoclonal antibody
→
disease-modifying therapy for Alzheimer's disease → |
| FDAApplicationNumber | BLA 761178 → |
| FDAApprovalDate | 2021-06-07 → |
| FDAApprovalType | accelerated approval → |
| firstInClass | first FDA-approved amyloid-targeting therapy for Alzheimer's disease → |
| halfLifeApproximate | 24 days → |
| hasGenericName |
Aduhelm
→
surface form: "aducanumab"
|
| indication |
Alzheimer's disease
→
mild Alzheimer's disease dementia → mild cognitive impairment due to Alzheimer's disease → |
| initialDoseRegimen | titration to 10 mg/kg → |
| legalStatusInUnitedStates | prescription only → |
| marketingAuthorizationStatusInEU | application withdrawn → |
| mechanismOfAction |
binds aggregated forms of amyloid beta
→
reduces amyloid-beta plaques in the brain → |
| molecularType | human monoclonal antibody → |
| requiresGeneticConsideration | APOE ε4 carrier status for ARIA risk → |
| requiresMonitoring | brain MRI for ARIA → |
| routeOfAdministration | intravenous infusion → |
| sponsorDecision | Biogen discontinued commercialization in the U.S. → |
| targetDiseaseStage | early Alzheimer's disease → |
| targets |
amyloid beta peptide
→
amyloid-beta plaques → |
| USMarketWithdrawalYear | 2024 → |
| withdrawnFromMarketInUnitedStates | true → |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form: "aducanumab"